Definition Of A Manufacturer Significant modification of a sunlamp product means recertification as a "manufacturer." Here are some examples from the FDA: "A replacement lamp will be considered compatible with (or equivalent to) another (original) lamp if: The replacement lamp will not cause any sunlamp product intended to use the original lamp to fail to comply with the standard or to become defective as defined by 21 CFR 1003.2, and; The lamp is as effective, within plus or minus 10 percent, as the original lamp, in causing erythema and melanogenesis." However, to harmonize with the international standard for sunlamps, the requirement that the lamps effectiveness be compared on the basis of melanogenesis will be removed and a new requirement based on the CIE nonmelanoma skin cancer action spectrum will be added. (See the section on coding systems for lamps below.) Protective Eyewear UV limits will remain the same as before, but standards for the visible region (> 400 nm) will include a more quantitative definition: "the luminous transmittance shall not be less than 1 percent over the 380 to 780 nm wavelength region and the unweighted transmittance ( 5 nm intervals) over the 400 to 550 nm region shall not exceed 5 percent." This second requirement is currently part of the international standard for sunlamp products (IEC 6-335-2-27). New MED Dose The currently used "CIELYTLE" erythema action spectrum will be replaced with the internationally-accepted CIE Reference action spectrum for erythema. The proposal includes the adoption of a maximum timer setting of 3 minimal erythema doses (MEDs) where an MED is defined as 200 J/m2-effective (wavelength-weighted with the CIE action spectrum). The limit of 3 MEDs provides a biologically-equivalent dose to what is currently used (4 MEDs), weighted with the CIELYTLE action spectrum and assuming that 1 MED equals 156 J/m2-effective. Limits for the old and new action spectrums are roughly equal to 600 J/m2-effective. Coding System For Lamps For determining replacement lamps—low pressure, fluorescent types—the following coding scheme shall be used: Wattage - Reflector type code - UV code. Wattage is the nominal lamp wattage, marked "watts" or "W." The reflector type code is defined as follows: O—for nonreflector lamps. B—for lamps with a broad reflector angle. N—for lamps with a narrow reflector angle. R—for lamps with a regular reflector. The following UV code shall be used: UV code = X/Y. X equals the total erythema effective UV irradiance over the range 250-400 nm, and Y equals the ratio of the CIE action spectrum effective UV irradiances.
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